BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONGUARD-2 CSTD LEUR-LOCK ADAPTOR

    MDR report key: 23980613 · Received January 6, 2026

    Report

    Report Number
    MW5181871
    Event Type
    Injury
    Date Received
    January 6, 2026
    Date of Event
    December 9, 2025
    Report Date
    December 30, 2025
    Manufacturer
    SIMPLIVIA HEALTHCARE LTD.
    Product Code
    ONB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT'S BEDDING WAS NOTED TO BE WET WHEN RN CAME TO ASSESS THE INFUSION PROGRESS AND PREPARE FOR PLATELET TRANSFUSION. RN NOTED THAT THE LEUR-LOCK AT INJECTION CAP WAS DISCONNECTED AND LAYING IN THE BED. PATIENT WAS FOUND TO BE IN SOAKED LINEN, SO PATIENT WAS ASSISTED WITH MOVING TO A CLEAN AREA AND TO IMMEDIATELY SHOWER WITH SOAP AND WATER. ROOM BLOCKED FOR CHEMOTHERAPY SPILL PRECAUTIONS AND PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47852 ONGUARD-2 CSTD LEUR-LOCK ADAPTOR CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB SIMPLIVIA HEALTHCARE LTD. UBM601

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention CYTARABINE.